Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-30 @ 12:31 AM
Study NCT ID:
NCT05752032
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-15
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Sponsor:
ICM Co. Ltd.
Organization:
Study Overview
Official Title:
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an observational study of the long term safety and efficacy of ICM-203.
Detailed Description:
Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: